Cleared Traditional

K870907 - INTRODUCER

K870907 is the FDA 510(k) clearance for INTRODUCER by Med Fusion Systems, Inc.. It is a Class 2 Cardiovascular device (product code DYB) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K870907 · Med Fusion Systems, Inc. · Cardiovascular device
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Apr 1987
Decision
35d
Days
Class 2
Risk

K870907 is an FDA 510(k) clearance for the INTRODUCER, PERCUTANEOUS. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Med Fusion Systems, Inc. (Norcross, US). The FDA issued a Cleared decision on April 9, 1987 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Med Fusion Systems, Inc. devices

Submission Details

510(k) Number K870907 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 1987
Decision Date April 09, 1987
Days to Decision 35 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 125d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DYB Introducer, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1340
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DYB Introducer, Catheter

All 399
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K870907.
PULL-APART INTRODUCER (SHEATH)
K873727 · Quinton, Inc. · Oct 1987
OVAL PULL-APART SHEATH/DILATOR
K873394 · Quinton, Inc. · Sep 1987
UNIPOLAR ENDOCARDIAL SCREW-IN LEAD, MODEL 1007M
K871208 · Pacesetter Systems · Jun 1987
PERCUTANEOUS INTRODUCER W/SIDE PORT 3 WAY STOPCOCK
K870374 · Daig Corp. · Mar 1987
MODIFICATION (MATERIAL CHANGE) OF PEEL-AWAY SHEATH
K864705 · Quinton, Inc. · Feb 1987
MODIFIED PEEL-AWAY INTRODUCER SET LINE
K864352 · Quinton, Inc. · Jan 1987